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House Republicans have asked all federal agencies to postpone rulemaking until President-elect Donald Trump’s administration and the newly elected Congress assume office next year. Read More
Three clinical trial designs incorporating real-world evidence were proposed by a working group consisting of members the FDA and industry, who said the trials could possibly be used in future regulatory decisions. Read More
Sen. Charles Grassley (R-Iowa) is calling on the Justice Department to reconsider testifying before the House Judiciary Committee on its settlement with Mylan, which resolved allegations that the company overcharged Medicaid for its allergy therapy, the EpiPen. Read More
Nicox, an international ophthalmic R&D company, announced it received a complete response letter related to its NDA for its cetirizine eye drop formulation AC-170. Read More
The EMA Management Board has advanced the development of a web portal that will provide free information on European medicines across the products’ lifecycle. Read More
The European Medicines Agency is investigating reports that India’s Wanbury Pharma, one of the largest exporters of the diabetes drug metformin, had more than half of its exports produced by an unlicensed supplier. Read More